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A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).
Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of SEP-380135 in Adults With Schizophrenia or With a Major Depressive Episode Associated With Bipolar I or II Disorder or Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2024-11-07
Completion Date
2025-09-12
Last Updated
2026-04-24
Healthy Volunteers
No
Interventions
SEP-380135
oral capsule.
Placebo
Placebo capsule.
Locations (1)
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States